Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8040700

FEI Number

3002806588

Entity Name

BAXTER PRODUCTOS MEDICOS, LTDA.

City/State/Country

1-7052 Cartago, CR

Establishment Address

PARQUE INDUSTRIAL DE CARTAGO, APARTADO, 1-7052 Cartago --, CR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BAXTER HEALTHCARE CORPORATION (Owner Number: 1417572)

Owner / Operator Contact Address

One Baxter Parkway, Deerfield, IL 60015, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Solution Sets, Extension Sets Continu-Flo Duo-Vent MICROMIX BCR COMPOUNDER All-In-One Two Chamber Container Automix 3+3/AS Compounder System REPEATER PUMP Extension Set MICROMIX COMPOUNDER AN Abacus Luer Lock Universal Spike EM2400 Pharmacy Compounder INTELLIFILL I.V. ExactaMix Pro 2400 Display Module - Refurbished ExactaMix Pro 2400 Display Module ExactaMix Pro 1200 Display Module - Refurbished ExactaMix Pro 1200 Display Module LOGIX Transfer Set REPEATER PUMP Tube Sets AUTOMIX 3+3 COMPOUNDER Solution Set Secondary Medication Set ContinuFlo Solution Set Control-A-Flo Duo-Vent Clearlink Continu-Flo Interlink Blood Recipient Set Clearlink System Stopcock and I.V. Solution Administration Sets with Stopcocks Clearlink Continu-Flo Interlink Flo-Gard Colleague Low Plasticizer Administration Sets Duo-Vent Continu-Flo Interlink Extension Set Solution Set .22 Micron Filter Interlink System Clearlink System Interlink System with Duo-Vent Spike Continu-Flo Solution Set Buretrol Solution Sets Neutral Luer Activated Device (One-Link Needle-free IV Connector) and Extension Sets Solution Set Clearlink System with Duo-Vent Spike Duo-Vent Clearlink Interlink Solutions Administration Sets with 0.2 Micron Filter Continu-Flo TUR Irrigation Set Cystoscopy Irrigation Set Arthroscopic Irrigation Set Interlink Uromatic Arthromatic 3 Lead Ext w/2 Interlink Inject Sit Interlink Blood Recipient Set Clearlink Interlink FENWAL BLOOD RECIPIENT SET Solution Administration Sets Paclitaxel Sets Duo-Vent Clearlink Interlink Clearlink Luer Activated Valve Neutral Luer Activated Device (One-Link Needle-free IV Connector) and Extension Sets with One-Link Needle-free IV Connec One-Link Solution Set with 1.2 Micron Air Eliminating Filter Solution Set w/1.2 Micron Air Eliminating Filter Interlink Clearlink Nitroglycerin Set with DUO-VENT Spike Duo-Vent Clearlink Solution Sets w/Capless Luer Valve Duo-Vent Clearlink Control-A-Flo Continu-Flo Buretrol Interlink Clearlink System Solution Set Solution Administration Set Interlink Clearlink Duo-Vent Continu-Flo Radiation Sterilized Extension Sets Control-A-Flo Interlink Continu-Flo Duo-Vent Buretrol Mini-Infuser Cystoscopy Irrigation Set TUR Irrigation Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2014-08-25
NEP	System/Device, Pharmacy Compounding	General Hospital	Class 2	880.5440	2007-07-05
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-03
BRZ	Set, Blood Transfusion	General Hospital	Class 2	880.5440	2017-11-09
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-03-07
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2013-03-07
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2010-07-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2009-08-10
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-11-09
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2016-01-11
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2007-12-03
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2007-12-03
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-03
BRZ	Set, Blood Transfusion	General Hospital	Class 2	880.5440	1997-07-10
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2025-04-02
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2025-04-02
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-04-02
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-01-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2011-10-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-12-20
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-06-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-03
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2015-04-17
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-12-03
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-03
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2019-05-30
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-03
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-03
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2017-11-09

Official Correspondent

Maha Nolasco

US Agent Details

Maha Nolasco Business: BAXTER HEALTHCARE CORPORATION Email: maha_nolasco@baxter.com Phone: (224) 2706181

Related Public Records

Same Entity

BAXTER HEALTHCARE CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014226707	BARDY DIAGNOSTICS, INC.	Bellevue, WA, US
3019257308	VIDEOMED SRL	LIMENA Padova, IT
1314492	Baxter Healthcare Corporation	MEDINA, NY, US
3007143268	Baxter Medical Systems GmbH + Co. KG	SAALFELD Thuringia, DE
8010130	BAXTER SA	LESSINES Hainaut, BE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04
K143446	Roche Diagnostics GmbH	Accu-Chek FlexLink Plus infusion set	2015-08-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

Similar Registrations

Registration Number	Establishment Name	Location
3018229072	INNOVATIVE HEALTH SCIENCES	Chester, NY, US
3030989877	INTERNATIONAL FILTER PRODUCTS DBA IFP MEDICAL	Sun Valley, CA, US
1047843	ISOMEDIX OPERATIONS INC.	SPARTANBURG, SC, US
3002807090	Sterigenics Germany GmbH	Wiesbaden Hesse, DE
3013319212	ICU MEDICAL, INC.	Lake Forest, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8040700. Last updated year: 2026. Please use registration number 8040700 when referencing this establishment in official correspondence.